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A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

About this trial

This is an interventional other trial for Healthy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy, male or female, between 18 and 45 years of age (inclusive).
Body mass index (BMI) between 20-30 kg/m2 (both inclusive)
No recent cannabis usage within 30 days from screening
Normal rage hepatic functions
No electrolytes abnormalities
Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges:
1. Body temperature between 35.0 to 37.5 °C
2. Systolic blood pressure, 90 to 150 mmHg*
3. Diastolic blood pressure, 60 to 90 mmHg*
4. Pulse rate, 50 to 90 beats per minute*.
5. *Blood pressure and pulse rate will be taken again in a standing position. After two minutes standing, there shall be no more than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure, associated with clinical manifestation of postural hypotension).

Exclusion Criteria:

Blood donation within 90 days
History of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastroenterology, endocrine, immunology, dermatologic, neurologic or psychiatric disorders
Subjects with a history of alcohol, drug abuse, chronic cannabis use within 2 years of study
Pregnant women
Subjects who used any prescription or OTC medication in the past 14 days with the exception of paracetamol or ibuprofen.
Sexually active males whose partner is of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP. Sexually active females of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP
Pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
Subjects who had postural drop of > 20 mmHg in systolic blood pressure at screening
Patients with heart failure,
Subjects with a history of psychotic state in the past or anxiety disorder,
Subjects at age of less than 30 years with a history of psychiatric disease in a first-degree family member
Subjects with a history of addiction or drug abuse

Sites / Locations

Ziv Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Single dose

Cross-Over food effect

Cross-Over product comparison

Cross-over route of administration comparison

Arm Description

Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4

2 doses: fasted and fed state with the same product: A1, A4, A5, B4

2 doses: in fasted state comparing A1 to A4

2 doses: in fasted state comparing oral administration to sublingual administration of A4

Outcomes

Primary Outcome Measures

Pharmacokinetic analysis of Cmax

Pharmacokinetic analysis of Tlag

Pharmacokinetic analysis of Tmax

Pharmacokinetic analysis of AUC(0-t)

Pharmacokinetic analysis of AUC(0-∞)

Pharmacokinetic analysis of %AUC extrapolated

Pharmacokinetic analysis of T1/2

Pharmacokinetic analysis of clearance from plasma (Cl/F)

Pharmacokinetic analysis of ratio of the Volume of distribution based on the terminal phase to the bioavailability (Vz/F)

Pharmacokinetic analysis of clearance from plasma dose normalized Cmax

Pharmacokinetic analysis of dose normalized AUC

Secondary Outcome Measures

Full Information

NCT ID

NCT04261166

First Posted

February 4, 2020

Last Updated

December 7, 2022

Sponsor

Breath of Life International Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04261166

Brief Title

A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract

Official Title

A Phase I Open Label Study to Assess the Single Dose Pharmacokinetics and Safety of Sublingual Administration of Tablets and Medicated Drops of Plant Cannabis Extract

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

July 24, 2019 (Actual)

Primary Completion Date

October 24, 2022 (Actual)

Study Completion Date

October 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Breath of Life International Pharma Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single dose

Arm Type

Experimental

Arm Description

Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4

Arm Title

Cross-Over food effect

Arm Type

Experimental

Arm Description

2 doses: fasted and fed state with the same product: A1, A4, A5, B4

Arm Title

Cross-Over product comparison

Arm Type

Experimental

Arm Description

2 doses: in fasted state comparing A1 to A4

Arm Title

Cross-over route of administration comparison

Arm Type

Experimental

Arm Description

2 doses: in fasted state comparing oral administration to sublingual administration of A4

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

Celixir 20 T1/C20- CBD 20%, THC 1%

Intervention Description

Medical Cannabis oil diluted in Olive oil. CBD 36.6 mg, THC 1.8 mg (6 drops)

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

Telixir 10 T2/C10 - CBD 2%, THC 10%

Intervention Description

Medical Cannabis oil diluted in Olive oil. CBD 0.6 mg, THC 3.1 mg (1 drop)

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

Equatir 10 T10/C10 - CBD 10%, THC 10%

Intervention Description

Medical Cannabis oil diluted in Olive oil. CBD 3.1 mg. THC 3.1 mg (1 drop)

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

C18T0.9 in MCT oil - CBD 18%, THC 0.9%

Intervention Description

Medical Cannabis (oil diluted in MCT oil). CBD 34.8 mg, THC 1.7 mg (6 drops)

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

T10/C2 - CBD 2%, THC 10%

Intervention Description

Medical Cannabis oil (diluted in MCT oil). CBD 0.6 mg, THC 3.1 mg (1 drop)

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

Tablet: CBD 40 mg, THC 2 mg

Intervention Description

Sublingual tablets. CBD 40 mg, THC 2 mg (1 tablet)

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

Tablet: CBD 30 mg, THC 5 mg

Intervention Description

Sublingual tablets. CBD 30 mg, THC 5 mg (1 tablet)

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

Tablet: CBD 40 mg

Intervention Description

Sublingual tablets. CBD 40 mg (1 tablet)

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

Tablet: CBD 40 mg

Intervention Description

Sublingual tablets. CBD 40 mg (1 tablet)

Primary Outcome Measure Information:

Title

Pharmacokinetic analysis of Cmax

Time Frame

0-12 hours post dose

Title

Pharmacokinetic analysis of Tlag

Time Frame

0-12 hours post dose

Title

Pharmacokinetic analysis of Tmax

Time Frame

0-12 hours post dose

Title

Pharmacokinetic analysis of AUC(0-t)

Time Frame

0-12 hours post dose

Title

Pharmacokinetic analysis of AUC(0-∞)

Time Frame

0-12 hours post dose

Title

Pharmacokinetic analysis of %AUC extrapolated

Time Frame

0-12 hours post dose

Title

Pharmacokinetic analysis of T1/2

Time Frame

0-12 hours post dose

Title

Pharmacokinetic analysis of clearance from plasma (Cl/F)

Time Frame

0-12 hours post dose

Title

Pharmacokinetic analysis of ratio of the Volume of distribution based on the terminal phase to the bioavailability (Vz/F)

Time Frame

0-12 hours post dose

Title

Pharmacokinetic analysis of clearance from plasma dose normalized Cmax

Time Frame

0-12 hours post dose

Title

Pharmacokinetic analysis of dose normalized AUC

Time Frame

0-12 hours post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy, male or female, between 18 and 45 years of age (inclusive). Body mass index (BMI) between 20-30 kg/m2 (both inclusive) No recent cannabis usage within 30 days from screening Normal rage hepatic functions No electrolytes abnormalities Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges: Body temperature between 35.0 to 37.5 °C Systolic blood pressure, 90 to 150 mmHg* Diastolic blood pressure, 60 to 90 mmHg* Pulse rate, 50 to 90 beats per minute*. *Blood pressure and pulse rate will be taken again in a standing position. After two minutes standing, there shall be no more than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure, associated with clinical manifestation of postural hypotension). Exclusion Criteria: Blood donation within 90 days History of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastroenterology, endocrine, immunology, dermatologic, neurologic or psychiatric disorders Subjects with a history of alcohol, drug abuse, chronic cannabis use within 2 years of study Pregnant women Subjects who used any prescription or OTC medication in the past 14 days with the exception of paracetamol or ibuprofen. Sexually active males whose partner is of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP. Sexually active females of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP Pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter. Subjects who had postural drop of > 20 mmHg in systolic blood pressure at screening Patients with heart failure, Subjects with a history of psychotic state in the past or anxiety disorder, Subjects at age of less than 30 years with a history of psychiatric disease in a first-degree family member Subjects with a history of addiction or drug abuse

Facility Information:

Facility Name

Ziv Medical Center

City

Zefat

ZIP/Postal Code

13100

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract

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